FDA Guidance

FDA Investigations Operation Manual 2007; Chapter 5.3, 2/07

$0.00

The Inspections Operation Manual is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors.

Chapter 5.3 provides FDA inspectors with instructions on collecting evidence. See section 5.3.8.3, Filmed or Electronic Records, and 5.3.8.4, Requesting and Working with Computerized Complaint and Failure Data, to help prepare your company for inspector’s requests during audits.

Issuing Body

FDA Guidance Documents

SKU: 300079 Categories: ,